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A Study of Izalontamab Brengitecan Versus Chemotherapy in Participants With Previously Untreated, Locally Advanced, Recurrent Inoperable, or Metastatic Triple-negative Breast Cancer Ineligible for Anti-PD(L)1 Drugs (IZABRIGHT-Breast01)


Active: Yes
Cancer Type: Breast Cancer
Unknown Primary
NCT ID: NCT06926868
Trial Phases: Phase II
Phase III
Protocol IDs: CA244-0008 (primary)
NCI-2025-03934
2024-519871-24
U1111-1316-1533
Eligibility: 18 Years and older, Male and Female Study Type: Treatment
Study Sponsor: Bristol-Myers Squibb
NCI Full Details: http://clinicaltrials.gov/show/NCT06926868

Summary

The purpose of this study is to assess the efficacy and safety of iza-bren, a bi-specific
antibody-drug conjugate against EGFR and HER3 with a topoisomerase inhibitor payload
versus treatment of physician's choice (TPC) (paclitaxel, nab-paclitaxel, carboplatin
plus gemcitabine, and capecitabine) for the treatment of first-line metastatic
triple-negative breast cancer (TNBC) or estrogen receptor (ER)-low, human epidermal
growth factor receptor 2 (HER2)-negative BC patients who are not candidates for
anti-PD(L)1 therapy and endocrine therapies.

Treatment Sites in Georgia

Northside Hospital Cancer Institute
1000 Johnson Ferry Road NE
Atlanta, GA 30342
404-303-3355
www.northside.com

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